Early Stage Breast CancerNCT06311357
Percent Weight Change in the Medical Supplement Group of Early Breast Cancer
A study testing Ensure in people with Early Stage Breast Cancer, run by Department of Medical Services Ministry of Public Health of Thailand at 1 site in Thailand.
Trial summary
The goal of this RCT is to compare percent weight change in early breast cancer who takes medical supplement or not, during treatment with chemotherapy (standard AC regimen). The main question is the change of weight (%) before and after complete treatment of breast cancer therapy. Read more about this study
- Who is it for?
- Ages 18 to 80 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Early Stage Breast Cancer
- What is being tested?
- Ensure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteThailand
- Study dates
- 12 Jul 2023to 30 Dec 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Histopathological confirmed diagnosis of breast cancer
- Breast cancer stage I-III
- Recieve adjuvant or neoadjuvant doxorubicin and cyclophosphamide at Rajavithi hospital
- LVEF >= 60% - ECOG score 0-1
Who cannot join
- No indication for chemotherapy
- Contraindication for chemotherapy
- Breast cancer stage IV
- Diabetic mellitus who requires insulin injection
- BMI >= 30 kg/m2 or <= 16 kg/m2
- Previously known other malignancies
Show all 11Show fewer
- Second primary cancer
- Previously received chemotherapy or radiotherapy
- Severe malnutrition with administration of TPN is indicated
- Pregnancy or lactation
- CKD stage 4-5
Trial locations and contacts
1 site in 1 country.
Thailand1 site, 1 recruiting
- Recruiting
Rajavithi hospital
Ratchathewi, Bangkok, 10400
Meitinarth Juntong, +66654415447, juntong.mei@gmail.com
About this study
Official title: Effects of Body Weight Change in the Medical Supplement Group in Patients With Early Breast Cancer During Chemotherapy: a Randomized, Controlled Trial
The goal of this RCT is to compare percent weight change in early breast cancer who takes medical supplement or not, during treatment with chemotherapy (standard AC regimen).
The main question is
- the change of weight (%) before and after complete treatment of breast cancer therapy.
Participants will be randomized into 2 group
- intervention group - receive medical supplement daily during chemotherapy treatment.
- control group - Nutritional advise during chemotherapy treatment.
Read the detailed description
- The rational is to prove the hypothesis is that, the effect of medical supplement with nutritional advise can prevent the reduction of body weight, malnutrition and treatment complication, which eventually to improve of the quality of life.
- Primary endpoint of the study is to compare the effect of medical supplement on percent weight change in early breast cancer who received chemotherapy in Rajavithi hospital. Secondary endpoints are nutritional status (PG-SGA), quality of life.
- Sample size formula based on Bernard R. Fundamentals of biostatistics. 5th ed. Duxbery: Thomson learning; 2000. Enrollment of 40 patients.
- Randomization into 2 groups. Intervention arm : receive medical supplement daily (1 drink = 6 scoops in 250 ml water, 2 drinks/day) with nutritional advise. Control arm : nutritional advise only. Duration of treatment is 12 weeks
- Enrollment and data monitoring is assessed by the staffs of oncology department in Rajavithi hospital and the data will be recorded in computer based information system.
- Data assessment on week 0,6,12 during chemotherapy treatment.
- Data analyzed by descriptive statistics to characterize patients at entry. We did the efficacy analyses with intention to treat population
- We did analyses with R version 3.3.0.
- Conditions
- Early Stage Breast Cancer
- Being tested
- Ensure
- Keywords
- Medical supplement, Weight change in early breast cancer treatment
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EnsureDietary supplement
Ensure 6 scoops dietary supplement powder in 250 ml of water, 2 drinks per days for 12 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Control | No intervention | Nutritional advise |
| Intervention | Experimental | Medical supplement and nutritional advise Receives: Dietary Supplement: Ensure |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percent weight change
The change of body weight (%) before and after chemotherapy treatment
Measured: 12 weeks
Secondary outcomes (3)
EORTC QLQ-C30
The change of Global Quality of life before and after chemotherapy treatment score
Measured: 12 weeks
Patient interpretation of the Patient-Generated Subjective Global Assessment
PG-SGA
Measured: 12 weeks
EORTC QLQ-BR23
The change of Global Quality of life before and after chemotherapy treatment score
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Mar 2024
- Study start12 Jul 2023
- Primary completion26 Apr 2024
- Study completion30 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Early Stage Breast CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Department of Medical Services Ministry of Public Health of Thailand
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Piyawan Tienchaiananda, Study director, Department of Medical Services Ministry of Public Health of Thailand
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06311357
- Sponsor's protocol ID
- 100/2566
- Status last verified
- Mar 2024
- First submitted
- 12 Dec 2023
- Last updated
- 27 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Due to this study is performed on single institution. The study protocol will be provided later on published article.
Publications
Muscaritoli M, Arends J, Bachmann P, Baracos V, Barthelemy N, Bertz H, Bozzetti F, Hutterer E, Isenring E, Kaasa S, Krznaric Z, Laird B, Larsson M, Laviano A, Muhlebach S, Oldervoll L, Ravasco P, Solheim TS, Strasser F, de van der Schueren M, Preiser JC, Bischoff SC. ESPEN practical guideline: Clinical Nutrition in cancer. Clin Nutr. 2021 May;40(5):2898-2913. doi: 10.1016/j.clnu.2021.02.005. Epub 2021 Mar 15.
PubMed 33946039Hebuterne X, Lemarie E, Michallet M, de Montreuil CB, Schneider SM, Goldwasser F. Prevalence of malnutrition and current use of nutrition support in patients with cancer. JPEN J Parenter Enteral Nutr. 2014 Feb;38(2):196-204. doi: 10.1177/0148607113502674.
PubMed 24748626Dewys WD, Begg C, Lavin PT, Band PR, Bennett JM, Bertino JR, Cohen MH, Douglass HO Jr, Engstrom PF, Ezdinli EZ, Horton J, Johnson GJ, Moertel CG, Oken MM, Perlia C, Rosenbaum C, Silverstein MN, Skeel RT, Sponzo RW, Tormey DC. Prognostic effect of weight loss prior to chemotherapy in cancer patients. Eastern Cooperative Oncology Group. Am J Med. 1980 Oct;69(4):491-7. doi: 10.1016/s0149-2918(05)80001-3.
PubMed 7424938Sukaraphat N, Chewaskulyong B, Buranapin S. Dietary Counseling Outcomes in Locally Advanced Unresectable or Metastatic Cancer Patients Undergoing Chemotherapy. J Med Assoc Thai. 2016 Dec;99(12):1283-90.
PubMed 29952503Ovesen L, Allingstrup L, Hannibal J, Mortensen EL, Hansen OP. Effect of dietary counseling on food intake, body weight, response rate, survival, and quality of life in cancer patients undergoing chemotherapy: a prospective, randomized study. J Clin Oncol. 1993 Oct;11(10):2043-9. doi: 10.1200/JCO.1993.11.10.2043.
PubMed 8410128Tienchaiananda P, Juntong M, Pintasiri P, Sa-Nguansai S, Payapwattanawong S, Maneenil K. Body weight change in a medical supplement group in patients with early breast cancer during chemotherapy: a randomized, controlled trial. Support Care Cancer. 2025 Mar 19;33(4):299. doi: 10.1007/s00520-025-09359-z.
PubMed 40106001
Study at a glance
From the registry record, last updated by the sponsor on 27 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Body Weight Change in the Medical Supplement Group in Patients With Early Breast Cancer During Chemotherapy: a Randomized, Controlled Trial
- ClinicalTrials.gov ID
- NCT06311357
- Acronym / sponsor ID
- 100/2566
- Conditions
- Early Stage Breast Cancer
- Keywords
- Medical supplement, Weight change in early breast cancer treatment
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Department of Medical Services Ministry of Public Health of ThailandOther government
- Study start
- 12 Jul 2023 (actual)
- Primary completion
- 26 Apr 2024 (actual)
- Study completion
- 30 Dec 2024 (estimated)
- First posted
- 15 Mar 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goal of this RCT is to compare percent weight change in early breast cancer who takes medical supplement or not, during treatment with chemotherapy (standard AC regimen).
The main question is
- the change of weight (%) before and after complete treatment of breast cancer therapy.
Participants will be randomized into 2 group
- intervention group - receive medical supplement daily during chemotherapy treatment.
- control group - Nutritional advise during chemotherapy treatment.
Detailed description
- The rational is to prove the hypothesis is that, the effect of medical supplement with nutritional advise can prevent the reduction of body weight, malnutrition and treatment complication, which eventually to improve of the quality of life.
- Primary endpoint of the study is to compare the effect of medical supplement on percent weight change in early breast cancer who received chemotherapy in Rajavithi hospital. Secondary endpoints are nutritional status (PG-SGA), quality of life.
- Sample size formula based on Bernard R. Fundamentals of biostatistics. 5th ed. Duxbery: Thomson learning; 2000. Enrollment of 40 patients.
- Randomization into 2 groups. Intervention arm : receive medical supplement daily (1 drink = 6 scoops in 250 ml water, 2 drinks/day) with nutritional advise. Control arm : nutritional advise only. Duration of treatment is 12 weeks
- Enrollment and data monitoring is assessed by the staffs of oncology department in Rajavithi hospital and the data will be recorded in computer based information system.
- Data assessment on week 0,6,12 during chemotherapy treatment.
- Data analyzed by descriptive statistics to characterize patients at entry. We did the efficacy analyses with intention to treat population
- We did analyses with R version 3.3.0.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control | No intervention | –Nutritional advise |
| Intervention | Experimental | Dietary Supplement: EnsureMedical supplement and nutritional advise |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Histopathological confirmed diagnosis of breast cancer
- Breast cancer stage I-III
- Recieve adjuvant or neoadjuvant doxorubicin and cyclophosphamide at Rajavithi hospital
- LVEF >= 60% - ECOG score 0-1
Key exclusion criteria (11 listed)
- No indication for chemotherapy
- Contraindication for chemotherapy
- Breast cancer stage IV
- Diabetic mellitus who requires insulin injection
- BMI >= 30 kg/m2 or <= 16 kg/m2
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| EnsureEnsure 6 scoops dietary supplement powder in 250 ml of water, 2 drinks per days for 12 weeks. | Dietary supplement | Intervention |
Primary outcome
Percent weight change
Time frame: 12 weeks
The change of body weight (%) before and after chemotherapy treatment
3 secondary outcomes
EORTC QLQ-C30
Time frame: 12 weeks
Patient interpretation of the Patient-Generated Subjective Global Assessment
Time frame: 12 weeks
EORTC QLQ-BR23
Time frame: 12 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Dec 2024.
- Results publication: PubMed 33946039Muscaritoli M, Arends J, Bachmann P, Baracos V, Barthelemy N, Bertz H, Bozzetti F, Hutterer E, Isenring E, Kaasa S, Krznaric Z, Laird B, Larsson M, Laviano A, Muhlebach S, Oldervoll L, Ravasco P, Solheim TS, Strasser F, de van der Schueren M, Preiser JC, Bischoff SC. ESPEN practical guideline: Clinical Nutrition in cancer. Clin Nutr. 2021 May;40(5):2898-2913. doi: 10.1016/j.clnu.2021.02.005. Epub 2021 Mar 15.
- Results publication: PubMed 24748626Hebuterne X, Lemarie E, Michallet M, de Montreuil CB, Schneider SM, Goldwasser F. Prevalence of malnutrition and current use of nutrition support in patients with cancer. JPEN J Parenter Enteral Nutr. 2014 Feb;38(2):196-204. doi: 10.1177/0148607113502674.
- Results publication: PubMed 7424938Dewys WD, Begg C, Lavin PT, Band PR, Bennett JM, Bertino JR, Cohen MH, Douglass HO Jr, Engstrom PF, Ezdinli EZ, Horton J, Johnson GJ, Moertel CG, Oken MM, Perlia C, Rosenbaum C, Silverstein MN, Skeel RT, Sponzo RW, Tormey DC. Prognostic effect of weight loss prior to chemotherapy in cancer patients. Eastern Cooperative Oncology Group. Am J Med. 1980 Oct;69(4):491-7. doi: 10.1016/s0149-2918(05)80001-3.
- Results publication: PubMed 29952503Sukaraphat N, Chewaskulyong B, Buranapin S. Dietary Counseling Outcomes in Locally Advanced Unresectable or Metastatic Cancer Patients Undergoing Chemotherapy. J Med Assoc Thai. 2016 Dec;99(12):1283-90.
- Results publication: PubMed 8410128Ovesen L, Allingstrup L, Hannibal J, Mortensen EL, Hansen OP. Effect of dietary counseling on food intake, body weight, response rate, survival, and quality of life in cancer patients undergoing chemotherapy: a prospective, randomized study. J Clin Oncol. 1993 Oct;11(10):2043-9. doi: 10.1200/JCO.1993.11.10.2043.
- Derived from this study: PubMed 40106001Tienchaiananda P, Juntong M, Pintasiri P, Sa-Nguansai S, Payapwattanawong S, Maneenil K. Body weight change in a medical supplement group in patients with early breast cancer during chemotherapy: a randomized, controlled trial. Support Care Cancer. 2025 Mar 19;33(4):299. doi: 10.1007/s00520-025-09359-z.
- Individual participant dataSharing planned: No. Due to this study is performed on single institution. The study protocol will be provided later on published article.
Related trials for Early Stage Breast Cancer
RecruitingObservational study
A Study to Assess Treatment Patterns and Treatment Adherence in Early HER2-positive Breast Cancer Participants After Treatment Decentralization
Early-stage HER2+ Breast Cancer
RecruitingPhase 2
Study of Patritumab Deruxtecan Plus Pembrolizumab With Other Anticancer Agents in Participants With High-Risk Early-Stage Triple-Negative or Hormone Receptor-Low Positive/HER-2 Negative Breast Cancer (MK-1022-010, HERTHENA-Breast-03)
Breast Neoplasms, Breast Cancer
RecruitingPhase 2
BRE-04: Window of Opportunity Trial of Preoperative Low Dose Azacitidine in High-Risk Early Stage Breast Cancer
Breast Cancer Invasive, Early-stage Breast Cancer
Active, not recruitingObservational study
Longitudinal ctDNA Surveillance for Older Women With ER+ Breast Cancer Who Omit Surgery
Breast Cancer
RecruitingObservational study
Collecting Blood Samples From Patients With and Without Cancer to Evaluate Tests for Early Cancer Detection
Acute Lymphoblastic Leukemia, Acute Myeloid Leukemia
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Piyawan Tienchaiananda study director
Department of Medical Services Ministry of Public Health of Thailand
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ensure in people with Early Stage Breast Cancer, run by Department of Medical Services Ministry of Public Health of Thailand at 1 site in Thailand.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 27 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Thailand. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Meitinarth Juntong (+66654415447, juntong.mei@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percent weight change (time frame: 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06311357, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Dec 2024.